Multicenter, randomized controlled study to compare early mini-invasive thoracoscopy to simple chest tube drainage in complicated parapneumonic effusions or pleural empyema. 100 patients will be recruited. Follow-up will be 3 months. It will be looked at the rate medical cure, the need for secondary interventions, death and duration of hospital stay. In a nested trial in 20 patients the intrapleural pharmacokinetics of linezolid (approved antibiotic agent) will be measured.

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

Medical cure without secondary Intervention

Death

Secondary Outcome Measures:

Duration of hospital stay

Radiological outcome

Duration of drainage

Total amount of drainage fluid

Estimated cost

Adverse events

Pleural pharmacokinetics of linezolid

Estimated Enrollment:

100

Study Start Date:

October 2005

Estimated Study Completion Date:

October 2008

Detailed Description:

Background Pleural empyema has a high morbidity and mortality. Until now it is not clear which method is best to initially drain the pus, especially in complicated effusions with septa.

The objective of this study is to compare the standard treatment of simple chest tube drainage to early mini-invasive medical thoracoscopy. In earlier studies medical thoracoscopy has been a safe and effective method in pleural diseases. However there is no prospective data available.

Methods We conduct a prospective randomized controlled multicenter study on 100 patients with complicated parapneumonic effusions with septa or empyema with frank pus. Patients will be randomized to receive either simple chest tube drainage or early medical thoracoscopy. The latter will be performed in local anaesthesia and analgosedation according to the standards set by the European Study on Medical Video-Assisted Thoracoscopy (ESMEVAT)-group. Fibrinolysis will be used routinely. In 20 patients a nested study on the intrapleural pharmacokinetics of linezolid as antibiotic agent will be performed.

Follow-up will be structured on day 1, day 7, before discharge and after 3 months including chest radiographs and clinical and laboratory evaluations.

Outcome Primary outcome will be medical cure without the need of secondary intervention or death.

As secondary outcome we will measure duration of hospital stay, adverse events.

Provisional agenda Start of study: October 2005 End of study: October 2007

Potential outcome & benefit The study should clarify the role of early medical thoracoscopy in patients with complicated parapneumonic effusions or pleural empyema. Different authors have speculated that early intervention could be preferable. On the other hand, in many centres worldwide patients are primarily treated by a simple chest tube with or without pleural fibrinolysis. In case of failure of simple drainage, but this means several “precious” days later, a more invasive procedure is needed. At that moment tight pleural septa have formed, and often a surgical VATS or thoracotomy in general anaesthesia becomes necessary. Therefore, this pivotal study could lead to changes in the management of patients with pleural empyema.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Septated pleural effusion (ultrasonography) in the context of a lower respiratory tract infection

Frank pleural empyema (pus)

Exclusion Criteria:

Fibrothorax

Tuberculous empyema

Medical thoracoscopy cannot be performed within 24 hours

Pregnancy

Inability to give informed consent

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00234208